We’ve gleefully detailed the plaintiffs’ utter failure in the Zostavax MDL to establish causation. Now, the Gardasil MDL likewise seems well on the way to a place on the list (along with Bone Screw, Aredia/Zometa, Taxotere, and Zantac) of MDLs that plaintiffs’ counsel wish they’d given a miss. Maybe plaintiffs will learn not to seek vaccine-related MDLs. Not long ago we discussed an excellent Gardasil preemption decision. Today’s post is about In re Gardasil Products Liability Litigation, 2025 WL 1782576 (W.D.N.C. Feb. 20, 2025), an interesting Fed. R. Evid. 702 decision that was actually decided a few weeks before the preemption decision, but only recently appeared on Westlaw/Lexis.
The issue in this Gardasil opinion – since it preceded the merits ruling on preemption – dealt with experts and preemption, something we speculated about shortly after Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019), but that has not received a lot of judicial attention since. Now that the Supreme Court has declared preemption to be a question of law for courts, not juries, to decide, what if any role can expert witnesses (particularly FDA experts) play? We commented in 2019:
Instead of juries hearing dueling testimony of plaintiff and defense FDA experts on whether some arcane CGMP was violated in some possibly causal fashion, judges should decide such issues, since the Albrecht Court has unanimously concluded that judges are “better equipped to evaluate” the intricacies of the FDA’s regulatory scheme. Purported FDA experts . . . regularly violate the limitation that expert witness should not offer conclusions of law, so confining them to testifying to judges rather than juries is more in keeping with the proper roles of expert witnesses generally.
Only a couple of cases have addressed this expert issue directly following Albrecht. The first happened right away. Delfino v. Medtronic, Inc., 2019 WL 2415049 (Minn. App. June 10, 2019), was an unpublished decision holding that, because “expert opinion as to a legal matter is generally inadmissible” in deciding preemption after Albrecht, a trial court “did not abuse its discretion by prohibiting [plaintiff’s expert] from opining on a legal question.” Id. at *12. The other is In re Zofran (Ondansetron) Products Liability Litigation., 57 F.4th 327 (1st Cir. 2023), which held:
[T]he question of whether the studies constitute newly acquired information [i]s a question of law. Expert testimony on questions of law is rarely admissible because such testimony cannot properly assist the trier of fact. To that end, [plaintiffs’ expert’s] opinion is likely inadmissible. Although experts can opine on the underlying factual questions, including providing interpretations of pharmaceutical studies, they provide little, if any, relevant assistance when they opine on the ultimate legal question of whether something is “newly acquired information.”
Id. at 340 (citations and quotation marks omitted).
The Gardasil opinion had more to say along these lines. It addressed dueling Rule 702 (don’t say Daubert) motions filed against both sides’ regulatory “experts.” Most of the discussion focused on the plaintiff’s expert. He had plenty of credentials. 2025 WL 1782576, at *2-3. However, since the issue was preemption, his opinions concerned what was ultimately a question of law.
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